Following the decline of the old-fashioned social taboos relating to sexuality and the introduction of molecules that effectively generate an erectile response in males, an increasing number of men consults urology and anthology specialists with a view to improving and/or curing sexual deficiencies which, until a few years ago, responded little, if at all, to conservative (non-surgical) treatments.
It is estimated that approximately 3 million men in Italy suffer from erectile dysfunction (ED) to some extent.
5-phosphodiesterase inhibitors, which improve the erectile function, have been marketed relatively recently, and have had some commercial success.
However, although these medicaments are certainly effective in improving the male erectile function in over 70% of cases, their contraindications, the sometimes serious side effects, and concern about taking chemical substances with possible multiple interactions, have greatly limited the use of these active substances, with the result that the commercial results have perhaps fallen below expectations. The enzyme 5-phosphodiesterase is present not only in the corpus cavernosum, but also in almost all the other organs, and these inhibitors, though selective, also perform an inhibitory action on other phosphodiesterases (4, 6, 11, 7, etc.) present in various known and unknown areas, the function of which is not fully understood.
Moreover, the need to take some of these substances as required (on demand), i.e. on the basis of sexual activity planned for a pre-set time, has further reduced patients' enthusiasm, leading to a very high drop-out rate from the treatment.
Moreover, in view of the high cost of the medicaments, the fact that they have low or no therapeutic effect, but only a symptomatic effect, and their total lack of efficacy on the libido, chronic treatment with 5-phosphodiesterase inhibitors and the use of molecules with a long half-life (Tadalafil) is difficult to achieve.
On the basis of experience obtained in years of studies and research into erectile dysfunction, and on the basis of knowledge of the type of andrology patients suffering from said disorder, it has been reached the conclusion that a medicament which acts on both the libido and the symptoms is required; it also needs to act constantly, without any limiting psychological side effects, and to perform also a possibly trophic action on the corpus cavernosum and improve its elasticity, which generally declines with age, leading to fibrosis (it should also be effective against Peyronie's disease or induratio penis plastica, which affects 3-6% of the male population).
However, the development of such a medicament would require years of very expensive experimentation.
There is therefore the need to find new medicaments for prevention and/or treatment of erectile dysfunction.